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Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Sponsor: National Cancer Institute (NCI)
Summary
This phase II randomized control trial assesses the effect of Urolithin A (Uro-A) supplementation compared to placebo in men with biopsy-confirmed prostate cancer undergoing radical prostatectomy (RP) progressive disease. A total of 90 men will be accrued and randomized 1:1 to receive a 1000 mg daily dose of Uro-A in two 250 mg capsules PO BID or two placebo capsules BID daily for 3 to 6 weeks prior to RP. The primary endpoint is to determine the effect of Uro-A on decreasing prostate tumor tissue oxidative stress (measured by 8-OHdG) compared to placebo.
Official title: A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-09-12
Completion Date
2027-05-01
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo collection of blood samples
Placebo Administration
Given PO
Urolithin A Supplement
Given PO
Locations (5)
Cedars Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States